DMT310-005 Topical in the Treatment of Acne Rosacea

Dermata Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Acne Rosacea

Treatments: Drug: Placebo Topical Powder; Drug: Topical Powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT05108025

DMT310-005

Details and patient eligibility

About

The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne rosacea.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient is male or non-pregnant female at least 18 years of age.

Clinical diagnosis of moderate to severe papulopustular acne rosacea as determined by:

Investigator's Global Assessment (IGA) at Randomization score of 3 or 4. Patient has at least 15 inflammatory lesions on the face

Patient is willing to apply the Investigational Product as directed

Patient is willing and able to comply with the protocol

Exclusion criteria

Patient is pregnant or planning to become pregnant Patient is taking a topical therapy on the face which may affect the patient's rosacea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups

Study Treatment 1

Experimental group

Description:

DMT310 Powder mixed with Hydrogen Peroxide

Treatment:

Drug: Topical Powder

Study Treatment 2

Experimental group

Description:

Placebo powder mixed with Hydrogen Peroxide

Treatment:

Drug: Placebo Topical Powder